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Laboratory Developed Tests (LDTs) in the U.S. are currently at a pivotal moment. Traditionally, these tests have been under enforcement discretion, but the FDA is now proposing significant regulatory changes.

Over the next five years, the FDA aims to phase out this discretion, introducing a framework that requires comprehensive submissions from LDT providers. This move aligns with the recent EU IVDR implementation, which brought similar oversight to LDTs and all In Vitro Diagnostics (IVDs) in Europe.

Interestingly, the U.S. proposal has already generated substantial feedback, with over a thousand comments submitted, many expressing opposition to the new regulations.

The panel explores the following critical aspects of this evolving regulatory landscape:

  • Impact Assessment: We'll explore the potential repercussions of the U.S.'s proposed LDT regulations.
  • Regulatory Timeline: Gain insights into the rule-making process and the expected timeline for implementation.
  • EU's Response: Learn how companies in the EU have adapted to increased oversight of LDTs.
  • Preparation Strategies: Discuss proactive measures that can be taken in anticipation of these changes.
  • Challenges Ahead: Identify the major hurdles companies might face during this transition.
  • Market Dynamics: Evaluate whether this represents an opportunity for IVD manufacturers to expand their market share, especially as smaller labs grapple with meeting the FDA's new expectations.

This session promises to be an enlightening exploration of the future of LDT regulation and its impact on the MedTech industry.

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  • Nancy Morrison, RAC – Vice President, Intelligence & Innovation
  • Margot Borgel, Ph.D. – Director, IVD Intelligence & Innovation
  • Eila Pattee, Principal Consultant
  • Andrew Lakey, Ph.D. – Senior Consultant
  • Theresa Miles – VP, Client Portfolio Management (moderator)

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